Actively Recruiting
Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Led by Xiwei XU · Updated on 2026-02-03
22
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Over 60% of head and neck squamous cell carcinoma (HNSCC) patients are diagnosed at a locally advanced stage. While standard treatments involve surgery and chemoradiotherapy, prognosis remains poor, with 50-60% experiencing local recurrence within two years. Neoadjuvant therapy can potentially reduce tumor burden, preserve organs, and lower distant metastasis risk. Despite the KEYNOTE-689 trial showing that adjuvant two-cycle pembrolizumab increased major pathological response to 9.8% in stage III-IVB HNSCC, this result remains insufficient. More effective immunotherapy-based combinations are urgently needed to improve long-term survival after neoadjuvant treatment. Preclinical and clinical evidence indicates that low-dose radiotherapy can activate the tumor immune microenvironment and synergize with immunotherapy. Based on this rationale, the present clinical trial will evaluate a neoadjuvant regimen combining LDRT with two cycles of an anti-PD-1 inhibitor in patients with surgically resectable, locally advanced HNSCC.
CONDITIONS
Official Title
Low-Dose Radiotherapy and Anti-PD-1 Immunotherapy as Neoadjuvant Treatment for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign and date the informed consent form.
- Untreated, histologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, or larynx) with CPS 61, classified as stage T3-4bN0M0 or T1-4bN1-3M0, corresponding to stage III-IVB according to the AJCC Staging System, 8th Edition.
- Deemed eligible for curative surgery based on surgeon's assessment.
- Age: 18 to 75 years.
- ECOG performance status of 0 or 1.
- Life expectancy greater than 6 months.
- At least one measurable lesion as per RECIST 1.1 criteria.
- Adequate organ function, defined as meeting all the following criteria (without receipt of blood products, colony-stimulating factors, or hematopoietic growth factors within 14 days prior to testing): Hemoglobin 65 90 g/L Absolute neutrophil count 65 1.5 �D7 10�B9/L Platelet count 65 100 �D7 10�B9/L Serum albumin 65 28 g/L Total bilirubin 64 1.5 �D7 upper limit of normal (ULN) ALT and AST 64 2.5 �D7 ULN Serum creatinine 64 1.5 �D7 ULN or creatinine clearance 65 50 mL/min Activated partial thromboplastin time (aPTT) and international normalized ratio (INR) 64 1.5 �D7 ULN (patients on a stable dose of anticoagulant therapy such as low molecular weight heparin or warfarin are eligible if INR is within the therapeutic range) Thyroid-stimulating hormone (TSH) 64 ULN; if abnormal, T3 and T4 levels must be evaluated, and patients with normal T3 and T4 levels are eligible.
- Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the treatment period and for 3 months after the last dose.
- Good compliance with the study protocol.
You will not qualify if you...
- Pregnant or lactating women.
- History of allergy to PD-1 inhibitors.
- History of other malignancies within the past 5 years or at the time of enrollment, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
- Uncontrolled cardiac symptoms or diseases, including heart failure NYHA Class II or higher, unstable angina, recent myocardial infarction within 1 year, or serious arrhythmias requiring intervention.
- Prior receipt of investigational drugs before the first dose of this study drug.
- Concurrent participation in another clinical study, except non-interventional or follow-up phase studies.
- Systemic corticosteroid treatment (>10 mg prednisone or equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except topical corticosteroids for local inflammation or prevention of allergic reactions.
- Administration of live vaccines within 4 weeks before first dose.
- Major surgery or severe trauma within 4 weeks before first dose.
- Severe infections requiring hospitalization within 4 weeks before first dose or signs of infection on baseline chest imaging within 2 weeks before first dose.
- History of active autoimmune diseases or syndromes, except stable vitiligo or resolved childhood asthma/allergies.
- History of immunodeficiency or organ/bone marrow transplantation.
- Active tuberculosis infection or history without adequate treatment.
- Active hepatitis B or hepatitis C infections.
- Known substance or alcohol abuse.
- Considered ineligible by investigator judgment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital,Sun Yat-sen University
Guangdong, China
Actively Recruiting
Research Team
X
Xiaoting Cai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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